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Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer

Phase 2
70 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer

There is no definite evidence of a superior therapy for advanced non-small cell lung cancer
in elderly patients. With the exception of one known study, single agent erlotinib has not
been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has
never been studied exclusively in the treatment naive elderly. This is an important
population that needs less toxic therapies.

Inclusion Criteria:

- Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or
recurrent after primary surgery or radiotherapy.

- ECOG PS 0-1

- 70 years of age or older

- Must have measurable disease

- ANC > 1500, platelets > 100,000

- Total bilirubin
- Able and willing to swallow and absorb oral medication

- Able and willing to sign consent

- Request archival diagnostic tissue for EGFR expression but not required

Exclusion Criteria:

- Proteinuria as demonstrated by UPC ratio >/= 1.0

- Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or
anti-angiogenesis agent (includes thalidomide)

- Prior treatment for advanced stage disease, with the exception of surgery or
radiation (no systemic)

- History of gross hemoptysis within 1 month of enrollment unless treated with surgery
or radiation

- Evidence of bleeding diathesis or coagulopathy or other serious/acute internal
bleeding within 6 months of enrollment.

- Current, ongoing treatment with full dose warfarin or equivalent

- Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet

- History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6
months. Clinically significant PVD

- Known CNS disease except for treated brain mets.

- Squamous cell histology

- Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives

- History of hypertensive crisis or hypertensive encephalopathy

- NYHA grade II or > CHF

- History of MI within 6 months of enrollment

- Major surgery, open biopsy, significant trauma within 28 days of enrollment

- Pregnancy, lactation

- Abdominal or other fistula, abcess, perforation

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy measure is progression free survival defined as the time from enrollment to documented progression of disease by radiologic imaging.

Outcome Time Frame:

Scans to be done after every 2nd cycle of treatment

Safety Issue:


Principal Investigator

Hossein Borghaei, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

April 2015

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Grand View Hospital Sellersville, Pennsylvania  18960
AtlantiCare Regional Medical Center Pomona, New Jersey  08240
Pennsylvania Oncology Hematology Associates Philadelphia, Pennsylvania  19107
Paoli Hospital Paoli, Pennsylvania  19301
Fox Chase Virtua Health Cancer Program at Memorial Mount Holly, New Jersey  08060
Abramson Cnacer Center, University of Pennsylvania Philadelphia, Pennsylvania  19104